Approve IRAS submission

Before approving submission of the relevant IRAS forms, the Clinical Division research manager must satisfied that the following are in place (where applicable):

Mandatory:

1. IRAS NHS R&D form and IRAS REC form. The forms must be signed and the final versions for the submission to be classed as a valid application.2. IRAS SSI3. Protocol (final REC approved/submitted version).4. Participant information sheet and consent form (final REC approved/submitted version on Trust headed paper)5. Study specific documentation approved by the REC (eg patient diary cards)6. REC favourable opinion letter (if available at time of submission to us)7. CI/PI CV, and all CVs for the research team listed in the SSI (signed and dated).8. Clinical Division authorisation – an email is sufficient evidence – please contact the Clinical Division Research Manager.

If applicable:

1. Certificate of ARSAC approval2. A copy of the MHRA CTA authorisation letter3. Confirmation of authorisation from the MHRA for any substantial amendments4. Confirmation of REC favourable opinion for any substantial amendments5. Any other approval documentation that is relevant to the study (NIGB approval, GTAC etc)6. Confirmation from support departments that their involvement is agreed (emails are acceptable proof)

The start point (Day 0) for the NIHR’s 30-day target to achieve NHS permission is the receipt of a valid R&D application pack.